Industry group HealthTech Ireland has called for greater alignment between the EU Artificial Intelligence (AI) Act and current regulatory requirements in advance of its implementation in Ireland.
In a submission to the government’s public consultation on the implementation of the Act, HealthTech Ireland said the text fails to address and provide clarity on many critical principles.
The submission says that in future, any AI healthcare solution will qualify as high-risk AI systems under the AI Act and medical technology manufacturers will therefore need to ensure compliance with existing regulations – such as the medical devices regulation (MDR)/in vitro diagnostic medical devices regulation (IVDR) – and the corresponding requirements under the AI Act.
HealthTech Ireland said there must be alignment between the different regulations in order to avoid duplication and delays in the approval process.
While the AI Act acknowledges the need for consistency, avoiding unnecessary additional burdens or costs, and allows for flexibility for AI systems providers, the text only translates these principles into clear legal rules with regard to some obligations, HealthTech Ireland says.
It is concerned that some of the current wording of Article 8 (2a) of the Act “leaves room for diverging interpretations among medical technology manufacturers and will lead to confusion, inconsistency, and ultimately delays to the delivery of safe and effective products to patients and healthcare systems”.
For example, the organisation said, “clarity is needed to confirm that a ‘substantial modification’ within the AI Act, as it relates to transitional provisions and new conformity assessments, aligns with the definition/interpretation outlined in MDR/IVDR and relevant guidance for change control for medical technologies that are AI systems”.
“In order to avoid legal uncertainty, it is essential to provide further clarity as to what extent conformity with the MDR and IVDR and related harmonised standards are presumed to be in conformity with the requirements set out within the AI Act,” the submissions says.
Given the extensive overlap between the type of documentation and information required for conformity assessment under the MDR/IVDR and the AI Act, it should be made explicit that manufacturers can leverage a single set of technical documentation.
MedTech Europe, of which HealthTech Ireland is a member, has previously argued that the AI Act does not specifically address clinical investigations and performance studies. The organisation, which represents the health technology sector across Europe, is concerned that devices classified as investigational devices per the MDR or devices for performance study per the IVDR would require an AI Act CE mark before undergoing clinical and performance evaluation.
In a statement, MedTech Europe said that, under the AI Act, there is a risk that investigational devices and those in performance studies may be deemed to be “put into service” or “placed on the market” and therefore may require an affixed CE-marking prior to their testing.
The organisation has recommended that these devices should follow the current MDR/IVDR approach and should “be exempted from the requirements of the AI Act, insofar as those processes respect patient safety and fundamental rights, such as those stipulated under GDPR”.
